Trial record 8 of 101 for:    "Anal cancer"

Assessing Drivers and Barriers to Follow-Up Screening for Anal Cancer in Men Who Have Sex With Men

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Laser Surgery Care
ClinicalTrials.gov Identifier:
NCT00501306
First received: July 12, 2007
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

This study is designed to identify barriers that prevent men who have sex with men from receiving doctor-recommended annual follow-up screenings for anal cancer. Men who are at the highest risk for developing anal cancer will be asked to complete a brief questionnaire (either via telephone or in writing). The questionnaire is designed to identify potential barriers to care-seeking behavior including, relationship status, financial constraints, highest level of education and knowledge about anal cancer and its precursors. The men who agree to participate in the study will then be organized into groups based on their history of coming in for follow-up screening visits after learning that they are at higher risk for developing anal cancer. These groups include 1) men that have come in for regular screening visits (at least once per year), 2) men who came in once and were then lost to follow-up, 3) men who came in for more than one screening visit and were then lost to follow-up, and 4) men who were previously lost to follow-up and then began coming in for screening again. By comparing the men's responses across the different groups, we hope to uncover key barriers and drivers to follow-up screenings for anal cancer.

The goal of this study is to evaluate the differences in questionnaire responses across cohorts that may impact care-seeking behavior.

We hypothesize that:

  • Patients who regularly comply with annual follow-up screening visits score higher on questions assessing knowledge of HPV and anal cancer.
  • Men in stable relationships are more likely to comply with annual screening visit recommendations.
  • Men who are educated by their primary care physicians about the importance of anal cancer screenings have higher screening rates.

Condition
Anal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessing Drivers and Barriers to Follow-Up Screening for Anal Cancer in Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by Laser Surgery Care:

Enrollment: 195
Study Start Date: June 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

200 subjects will be selected out of a pool of MSM patients in Dr. Stephen Goldstone's private medical practice, Laser Surgery Care, who have in the past and/or are currently being screened for anal dysplasia.

Subjects who come into the office for a follow-up appointment for anal condyloma and/or anal dysplasia treatment will be asked to participate in the study. If written consent is provided, subjects will be asked to complete a written questionnaire.

Subjects will also be selected out of a pool of patients who have been lost to follow-up, defined as having failed to come in for a follow-up visit > 12 months after their last appointment for treatment or screening for anal condyloma and/or anal dysplasia. These subjects will be contacted via telephone and asked to participate in a brief telephone interview (approximately 14 minutes in duration). The interview is identical to the written questionnaire. At the conclusion of the interview, subjects will be given the opportunity to schedule a follow-up appointment.

Medical records for all subjects who agree to participate in the study will be used to confirm screening visit history as well as history and severity of dysplasia. In addition, HIV status will also be confirmed by review of the medical chart. Data will be entered into an anonymous medical record summary sheet. Information will then be entered into an electronic database identified only by subject number.

Subjects will be divided into cohorts based on follow-up care seeking behavior: 1) those who come in for regular screening defined as at least once per year, 2) those who came in once and were lost to follow-up, 3) those who came in for more than one screening visit and were then lost to follow-up, and 4) those who were previously lost to follow-up and then began coming in for screening again. Questionnaire responses will be compared across cohorts to determine which variables differ significantly. t-Tests, one way, and multivariate analysis of variance, and correlation analysis will be used as indicated by variable type.

Patients will not receive any compensation for their participation in the study.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients seen in the clinical practice that either had screening for dysplasia, stopped having screening or returned for screening after a period of absence.

Criteria

Inclusion Criteria:

  • MSM patients in Dr. Stephen Goldstone's private surgical practice who previously tested positive for one of the known HPV subtypes (HPV types 6, 11, 16, 18, 31, 33 and 35) and developed condyloma and/or dysplasia in the anogenital region.

Exclusion Criteria:

  • Failure to provide consent to participate in the telephone or written questionnaire.
  • Development of anal cancer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501306

Locations
United States, New York
Laser Surgery Care
New York, New York, United States, 10011
Sponsors and Collaborators
Laser Surgery Care
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Stephen E. Goldstone, M.D. Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: Stephen Goldstone, M.D., Laser Surgery Care
ClinicalTrials.gov Identifier: NCT00501306     History of Changes
Other Study ID Numbers: 07-0337-2, 32873
Study First Received: July 12, 2007
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Laser Surgery Care:
Condyloma Accuminata
Low Grade Squamous Intraepithelial Lesion
High Grade Squamous Intraepithelial Lesion
Anal Cancer Screening

Additional relevant MeSH terms:
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 15, 2014